Registration Dossier
Registration Dossier
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EC number: 941-225-2 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 March 2007 to 06 April 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, test procedure in accordance with OECD 404 methods, meets generally accepted scientific principles, acceptable for assessment. GLP compliant.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- hexasodium 6-amino-3-[(1E)-2-{7-[(1E)-2-{4-[(1E)-2-(4-amino-2-hydroxy-6-sulfonatonaphthalen-1-yl)diazen-1-yl]phenyl}diazen-1-yl]-8-hydroxy-6-sulfonatonaphthalen-2-yl}diazen-1-yl]-4-hydroxynaphthalene-2-sulfonate 6-amino-3-[(1E)-2-{7-[(1E)-2-{4-[(1E)-2-(4-amino-6-sulfonatonaphthalen-1-yl)diazen-1-yl]phenyl}diazen-1-yl]-8-hydroxy-6-sulfonatonaphthalen-2-yl}diazen-1-yl]-4-hydroxynaphthalene-2-sulfonate
- EC Number:
- 941-225-2
- Molecular formula:
- not applicable
- IUPAC Name:
- hexasodium 6-amino-3-[(1E)-2-{7-[(1E)-2-{4-[(1E)-2-(4-amino-2-hydroxy-6-sulfonatonaphthalen-1-yl)diazen-1-yl]phenyl}diazen-1-yl]-8-hydroxy-6-sulfonatonaphthalen-2-yl}diazen-1-yl]-4-hydroxynaphthalene-2-sulfonate 6-amino-3-[(1E)-2-{7-[(1E)-2-{4-[(1E)-2-(4-amino-6-sulfonatonaphthalen-1-yl)diazen-1-yl]phenyl}diazen-1-yl]-8-hydroxy-6-sulfonatonaphthalen-2-yl}diazen-1-yl]-4-hydroxynaphthalene-2-sulfonate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
Test system
- Type of coverage:
- semiocclusive
- Controls:
- no
- Amount / concentration applied:
- 0.5 g of test material
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- up to 72 hours
- Number of animals:
- 4 animals
- Details on study design:
- A single 4-hour, semi-occluded application (0.5 g) of the test material was administered to the intact skin of three rabbits. Skin reactions were recorded 1, 24, 48 and 72 hours after administration.
3 minute and 1-hour semi-occluded applications (0.5 g) of the test material were administered to the intact skin of one rabbit. Skin reactions were recorded 1,24, 48 and 72 hours after administration.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 72 h
- Score:
- ca. 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 72 h
- Score:
- ca. 0
- Reversibility:
- fully reversible
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24, 72 h
- Score:
- ca. 0
- Max. score:
- 8
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritant / corrosive response data:
- non irritant
- Other effects:
- Skin reactions following a 4-hour exposure period: Well- defined erythema and very slght oedema were noted at one trated skin site one hour after patch removal. No evidence of skin irritation was noted at one treated skin site one hour after patch removal. No evidence of skin irritation was noted at two treated skin sites throughout the observation period or at the remaining treaed skiin site at the 24-hour observation.
Skin reactions following 3-minute and 1 hours exposure periods: black/purple-coloured staining was noted at all treated skin sites throughout the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 0.
Therefore the tested item is to be considered as non-irritant to the skin of rabbits. - Executive summary:
The primary irritation effect on Direct Black 80 was assessed following OECD 404. The result show no irritation on rabbit skin therefore the tested item is to be considered as non-irritant to skin.
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